Consulting Wallah › Device Explorer › Hearing & audiology › Air-conduction hearing aid, canal
Device Explorer · FDA GUDID · GMDN 41209

Air-conduction hearing aid, canal

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal

US‑registered devices4,433in commercial distribution
Companies23labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Starkey Laboratories, Inc.1,21827%
Widex A/S75817%
Gn Hearing A/S71116%
Oticon A/S3358%
Sbo Hearing A/S2536%
Zhongshan Tianle Hearing Technology Co., Ltd.2486%
Bernafon Ag1884%
Unitron Hearing Ltd1864%

Top labelers

CompanyDevicesShare
Starkey Laboratories, Inc.1,21827%
Widex A/S75817%
Gn Hearing A/S71116%
Oticon A/S3358%
Sbo Hearing A/S2536%
Zhongshan Tianle Hearing Technology Co., Ltd.2486%
Bernafon Ag1884%
Unitron Hearing Ltd1864%
Audina Hearing Instruments, Inc.1113%
Sonic Innovations, Inc.1042%
Ws Audiology Usa, Inc.712%
Hansaton Akustik Gmbh521%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Relate3.1 Platinum 312 NW ORelate3.1 Platinum 10 NW OPhonak Virto I70-TitaniumPhonak Virto I90-TitaniumPhonak Virto I30-10 NW OPhonak Virto I50-10 NW OPhonak Virto I70-10 NW OPhonak Virto I90-10 NW OPhonak Lyric4UnitronPhonak BrandPHONAKPhonakAcoSoundAcosoundZEPP CLARITY ONE Earwax Guard

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OSMHearing aid, air conduction with wireless technology2,377
KLWMasker, tinnitus1,793
ESDHearing aid, air conduction861
LRBFace plate hearing aid727
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr551
ESDHearing Aid, Air-Conduction, Prescription454

GMDN & GCC registration

  • GMDN code 41209 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 54% · OTC 6%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many air-conduction hearing aid, canal products are registered in the US?

4,433 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Air-conduction hearing aid, canal", from 23 companies. The largest labeler is Starkey Laboratories, Inc. with 27% of records.

Which FDA product codes apply?

OSM (Hearing aid, air conduction with wireless technology), KLW (Masker, tinnitus), ESD (Hearing aid, air conduction), LRB (Face plate hearing aid)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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